When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.
- ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO 14971
- System Impact Assessment: A Risk Management Framework For A COVID World
- Understanding the Three Major Challenges Limiting Innovation In Tissue Engineering
- New Approaches In Patient Tracking For The Rare Disease Sector
- Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
- What’s A “Biopharma CDMO”?
- You Don’t Know Phlow: The Backstory Of A Misread Biopharma Start-Up
System Impact Assessment: A Risk Management Framework For A COVID World
Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.
Understanding the Three Major Challenges Limiting Innovation In Tissue Engineering
The regenerative medicine sector, comprised of tissue engineered products and cell and gene therapies, has grown rapidly over the past decade, including significant therapeutic advances that offer the prospect of optimizing and transforming patient care. There has been a dramatic increase in the number of approved cell and gene therapies and available funding for these products, and yet both progress in development programs and approvals for tissue engineered medical products (TEMPs) have lagged behind.
New Approaches In Patient Tracking For The Rare Disease Sector
While we have seen exponential growth in the effort to develop drugs to treat rare diseases in the 30 years since the Orphan Drug Act was introduced, unique challenges remain. Awareness of rare diseases is often low among stakeholders including physicians, healthcare providers, payers, and even patients themselves; trial protocols and regulatory pathways may be unclear, especially for investigational rare disease drugs that are first-in-class; and data on disease incidence, onset, progression, and burden are often limited.
Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.
Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products
This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"
Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity
Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants.
Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions
By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.
How EMD Serono Is Bringing Diverse Patient Voices Together
The pandemic has created an opportunity to address some of the causes underlying clinical care inequities. And while combatting these issues will take time, much can be done by first addressing the gap for minorities in clinical trials. This is a topic I am passionate about both personally and professionally as a female Hispanic chief medical officer.
PHARMA OUTSOURCING WHITE PAPERS
Lipid Formulations To Enhance Bioavailability In Early Development
To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.
It Hasn’t Been Easy For Pharma To Be Green
Most of the drugs coming to market today are acquired by large or mid-size pharma companies from small biotech companies. Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package – one that includes a proven commercialization process minimizing toxic waste that pose safety concerns or require costly remediation.
A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.
Digital Manufacturing Of Biologics
In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities.
Virus Safety For Continuous Processing
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
Principles Of Raman Spectroscopy And Application To Pharmaceutical Development
Discover the basic principles of Raman spectroscopy, how it is used to analyze a chemical compound’s structure, and further provides an example of how this technique is used to analyze amorphous material created through a hot melt extrusion process.
COVID-19 AND YOUR SUPPLY CHAINS
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